NCT02038374

Brief Summary

Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli. Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation. Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

10 months

First QC Date

September 12, 2013

Last Update Submit

August 29, 2014

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

  • analysis of bronchial biopsies

    Number of ciliated cells(units) versus cells(units) with mucus found by fields of interface of the culture

    12 months

Study Arms (2)

severe asthma atopic

EXPERIMENTAL
Procedure: biopsies

asthma non atopic

EXPERIMENTAL
Procedure: biopsies

Interventions

biopsiesPROCEDURE
asthma non atopicsevere asthma atopic

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children 0-18 years
  • patients followed regularly for at least one year.
  • The diagnosis of asthma is increased according to the criteria of the Global Initiative for Asthma (GINA): children with a history of recurrent episodes of bronchial obstruction.
  • children with severe asthma defined by the American Thoracic Society (ATS): Severe asthma is defined by the presence of a major criterion: the need for high doses of inhaled corticosteroids (budesonide dose equivalent 400 micro g) and least two of the five minor criteria:
  • The daily use of beta 2 long-acting or short-term daily action (\<4 years) or anti-leukotrienes associated with inhaled corticosteroids Daily or almost daily use of beta-2 short-acting Permanent-bronchial obstruction (FEV \<80% predicted FEV)
  • At least one emergency department visit for asthma exacerbations in France
  • At least 3 courses of oral corticosteroids per year

You may not qualify if:

  • parents' refusal to participate in the study
  • refusal children to participate pathology underlying cardiac, neuromuscular, immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

January 16, 2014

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

April 1, 2015

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

FR(1)